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RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) said this week it is approaching a pivotal stretch of clinical and regulatory milestones for lorundrostat, its lead drug candidate for difficult-to-treat …
Mineralys Flags Key Data Readouts as Lorundrostat Nears FDA Decision Read More
WAYNE, PA — Aclaris Therapeutics Inc. (NASDAQ: ACRS) said positive interim data from its first-in-human study of ATI-052 are accelerating the experimental drug’s push toward later-stage trials, signaling what the …
Early Trial Data Puts Aclaris’ ATI-052 on Fast Track Toward Bigger Bets Read More
NEWTOWN SQUARE, PA — ArriVent BioPharma has dosed the first patient in a global Phase 3 study that could reshape first-line treatment for a small but hard-to-treat group of lung …
Firmonertinib Trial Aims to Crack a Long-Standing Lung Cancer Treatment Gap Read More
MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) said it will begin enrolling patients in January 2026 in a large, long-term study designed to assess whether its experimental Parkinson’s disease …
Annovis Launches 3-Year Parkinson’s Study to Test Long-Term Promise of Drug Read More
NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) said interim results from a mid-stage clinical trial suggest its experimental COVID-19 treatment ratutrelvir may offer a differentiated alternative to Paxlovid, with …
New COVID Pill Shows Promise Against Paxlovid in Early Head-to-Head Trial Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) said it has completed U.S. enrollment for a Phase 2 clinical study testing a needle-free treatment for a common form of skin …
Medicus Fills Phase 2 Trial, Eyes FDA Talks for Needle-Free Skin Cancer Read More
WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) reported positive topline results from a mid-stage clinical trial that positions its lead drug candidate as a potential first approved treatment for …
Rare Disease Breakthrough? Palvella Reports Strong Phase 2 Results Read More
WASHINGTON, D.C. — The Food and Drug Administration moved aggressively in mid-December to speed promising drug reviews, loosen long-standing evidence barriers, strengthen food recall enforcement, and court private-sector innovation, signaling …
FDA Accelerates Cures, Cracks Down on Recalls, and Rewrites the Rules of Review Read More
WILMINGTON, DE — Incyte (Nasdaq: INCY) reported strong early-stage clinical results for an experimental precision antibody that sharply reduced disease markers in patients with essential thrombocythemia, bolstering hopes for a …
Incyte’s Precision Antibody Delivers Striking Results in Rare Blood Cancer Read More
PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) reported new late-stage clinical data showing its experimental epilepsy drug EPX-100 delivered sharp and sustained seizure reductions in patients with …
Harmony’s Epilepsy Drug Cuts Seizures in Half in Key Late-Stage Study Read More